title: Filgrastim XM02 (Tevagrastim®) after autologous stem cell transplantation compared to lenograstim: favourable cost-efficacy analysis.
abstract: OBJECTIVE
  Granulocyte colony-stimulating factors (G-CSFs), filgrastim and lenograstim, are recognised to be useful in accelerating engraftment after autologous stem cell transplantation. Several forms of biosimilar non-glycosylated G-CSF have been approved by the European Medicines Agency, with limited published data supporting the clinical equivalence in peripheral blood stem cell mobilisation and recovery after autologous stem cell transplantation.
  
  
  METHODS
  With the aim of comparing cost-effective strategies in the use of G-CSF after autologous stem cell transplantation, we retrospectively evaluated 32 patients consecutively treated with biosimilar filgrastim XM02 (Tevagrastim) and 26 with lenograstim. All patients received G-CSF (biosimilar or lenograstim) at a dosage of 5 mcg/kg/day subcutaneously from day 5 to absolute neutrophil count of 1500/mmc for three days.
  
  
  RESULTS
  The median time to absolute neutrophil count engraftment was 11 days for the filgrastim XM02 group and 12 days for the lenograstim group. As for platelets recovery, the median time was 12 days in both groups. The median number of G-CSF vials used for patients was 9.5 for Tevagrastim and 10.5 for lenograstim, reflecting a mean estimated cost of about 556.1 euros for Tevagrastim versus 932.2 euros for lenograstim (p< 0.001). The median days of febrile neutropenia were 1.5 and 1 for filgrastim XM02 and lenograstim, respectively. No adverse event related to the use of XM02 filgrastim was recorded.
  
  
  CONCLUSIONS
  In our experience, filgrastim XM02 and lenograstim showed comparable efficacy in shortening the period of neutropenia after cytoreduction and autologous stem cell transplantation, with a favourable cost effect for filgrastim XM02.
authors.affiliation: Division of Haematoncology, European Institute of Oncology, Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Gardellini
authors.forename: F
authors.initials: F
authors.lastname: Gigli
authors.forename: A
authors.initials: A
authors.lastname: Babic
authors.forename: G
authors.initials: G
authors.lastname: Andreola
authors.forename: D
authors.initials: D
authors.lastname: Radice
authors.forename: S
authors.initials: S
authors.lastname: Sammassimo
authors.forename: G
authors.initials: G
authors.lastname: Martinelli
authors.forename: D
authors.initials: D
authors.lastname: Laszlo
keywords: autologous bone marrow transplantation; biosimilar G-CSF; engraftment; filgrastim; lenograstim